MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24704
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device component was left inside the patient.The balloon protector was not removed prior to introducing a 2.5mm x 80mm x 150cm coyote balloon catheter into the patient.The balloon protector sleeve came off and went down the patient's artery and was not able to be removed.The procedure was immediately stopped.No patient complications were reported and the patient was doing okay.
Event or Problem Description
It was reported that a device component was left inside the patient.The balloon protector was not removed prior to introducing a 2.5mm x 80mm x 150cm coyote balloon catheter into the patient.The balloon protector sleeve came off and went down the patient's artery and was not able to be removed.The procedure was immediately stopped.No patient complications were reported and the patient was doing okay.It was further reported that patient complications occurred.Protective outer sheath from 2.5x80x150 coyote balloon was retained in patients body, and the procedure performed was: exploration distal left anterior tibialis artery with removal of foreign body and vein patch angioplasty.Preoperative diagnosis was non- healing ulcer on left foot, and the procedure performed was: percutaneous ultrasound guided dynamic aortogram with bilateral lower extremity runoff with interpretation left popliteal and anterior tibialis artery directional atherectomy with left popliteal artery drug coated balloon angioplasty and left at angioplasty.Patient was discharged home on 12dec2019.No prognosis notes found yet.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9532593
• Report Number: 2134265-2019-16242
• Device Sequence Number: 18929527
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0021410727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR